MAUDE Adverse Event Report: CORDIS US. CORP SABER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48002030X

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, when preparing to use the 2mm 30cm saber balloon, it was found that the guidewire would not come out of the tail seat of the guidewire lumen.Instead came out of the hole where the balloon was inflated, and therefore could not be used.A new balloon of the same model was used to ensure that the procedure was performed properly.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.

Manufacturer Narrative

As reported, when preparing to use the 2mm 30cm saber percutaneous transluminal angioplasty (pta) balloon, it was found that the guidewire would not come out of the tail seat of the guidewire lumen.Instead came out of the hole where the balloon was inflated, and therefore could not be used.A new balloon of the same model was used to ensure that the procedure was performed properly.There was no reported injury to the patient.Multiple attempts were made without success for additional information.One picture related to the reported event was evaluated.In the image provided the hub section of the catheter is observed and a red arrow can be seen drawn over the hub.No anomalies of the product are noted on the picture provided.The device was returned for analysis.A non-sterile saber 2mm x 30cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing an internal kink in the body/shaft portion located in the balloon entrance port area.The balloon was received deflated.Functional testing was performed, an inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.The balloon inflation/deflation mechanism was working as intended.During guidewire insertion/withdrawal testing, an impeded condition was observed in the guidewire lumen.The strain relief was removed to observe the conditions of the distal end of the device¿s hub.The observed conditions were adequate according to the expected design.The guidewire lumen was straightened up by pulling the guidewire lumen and the guidewire was introduced and passed through the guidewire lumen along the entire length of the device entering through the distal tip and exiting in the proximal port exit.The balloon was inflated again after the complete insertion of the guide wire looking for any evidence related to a loss of pressure in the balloon that could be related to the reported event.No leak in the distal tip nor loss of pressure could be confirmed that could evidence the prescence of a permeability between the guide wire lumen and the inflation lumen due to the reported body/shaft ¿ puncture cut malfunction code.A product history record (phr) review of lot 82263535 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft-puncture cut" was not confirmed, as no leakage or puncture was observed along the body/shaft during balloon inflation and guidewire insertion.However, a secondary failure of ¿body/shaft ¿ kinked/bent¿ was confirmed during analysis as the guidewire lumen was kinked up inside the hub of the balloon port¿s.The exact cause of this failure cannot be determined.During visual inspection the guidewire lumen can be seen kinked inside the luer hub.Once the area was straightened the guidewire passed with no difficulty.Additionally, functional analysis was performed successfully with no leakage or punctures noted on the balloon material, shaft, or inner lumen.Therefore, based on the information available it appears handling of the device with the unknown concomitant guidewire and procedural factors may have contributed to the reported event.The guidewire lumen appears to have been induced to forces that exceeded the material strength causing it to kink up inside the hub port.The concomitant guidewire used in the procedure was not provided and compatibility cannot be confirmed.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.¿.

Event Description

As reported, when preparing to use the 2mm 30cm saber balloon, it was found that the guidewire would not come out of the tail seat of the guidewire lumen.Instead came out of the hole where the balloon was inflated, and therefore could not be used.A new balloon of the same model was used to ensure that the procedure was performed properly.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.One picture related to the reported failure was evaluated.Image evaluated: as part of the picture, ir could be observed the hub section of the catheter.A red arrow is drawn over the hub.No other anomalies of the product can be noticed at the attached picture.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82263535 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when preparing to use the 2mm 30cm saber balloon, it was found that the guidewire would not come out of the tail seat of the guidewire lumen.Instead came out of the hole where the balloon was inflated, and therefore could not be used.A new balloon of the same model was used to ensure that the procedure was performed properly.There was no reported injury to the patient.The device will not be returned for evaluation as multiple attempts were made without success.One picture related to the reported failure was evaluated.Image evaluated: as part of the picture, ir could be observed the hub section of the catheter.A red arrow is drawn over the hub.No other anomalies of the product can be noticed at the attached picture.

• Brand Name: SABER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17774717
• MDR Text Key: 323746174
• Report Number: 3007635982-2023-00299
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069233
• UDI-Public: (01)20705032069233(17)250930(10)82263535
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 48002030X
• Device Lot Number: 82263535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6FEXOSEAL; TEMPO CONTRAST TUBE